To reduce the influence of adherence as a factor in the interpretation of efficacy results, IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method as Daily Monitored Adherence (DMA). IPM014B is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the feasibility of utilizing the DMA method for a large-scale phase III efficacy study.

Eligibility

Ages Eligible for Study:

18 Years to 40 Years (Adult)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Women 18 to 40 years of age inclusive who can give written informed consent

Available for all visits and consent to follow all procedures scheduled for the study

Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method

Healthy and self-reported sexually active

HIV-negative as determined by a HIV rapid test at time of enrollment

On a stable form of contraception and willing to continue on this stable method of contraception, OR, Have undergone surgical sterilisation at least 3 months prior to enrollment

In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

Upon pelvic/speculum examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the investigator

Asymptomatic for genital infections at the time of enrollment

Willing to refrain from use of vaginal products or objects within 14 days prior to enrollment and for the duration of the study

Willing to answer acceptability and adherence questionnaires throughout the study

Willing to refrain from participation in any other research study for the duration of this study

Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures

Exclusion Criteria:

Currently pregnant or last pregnancy outcome within 3 months prior to enrolment

Currently breast-feeding

Participated in any other research study within 60 days prior to screening

Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation

Any Grade 2, 3 or 4 baseline haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Experiences

Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment

Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex

Any serious acute, chronic or progressive disease

Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917904